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Completed

NCT Number: NCT04188834

Effects of Sensory Flicker and Electrical Flicker Stimulation

The study will evaluate whether sensory flicker can modulate neural activity of deep brain regions in humans, and whether it can have relevant effects on behavior. Moreover, it will compare those effects to the gold-standard method of modulating brain circuits, direct electrical stimulation of the brain (the same mechanism as deep brain stimulation), using a powerful within-subjects design.

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Key information

Conditions

Brain Diseases Central Nervous System Diseases Nervous System Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Emory University Hospital

Atlanta, Georgia, 30322, United States

About this study

Clinical trials have explored the modulation of brain circuits to treat several brain disorders, including Parkinson's Disease, Alzheimer's Disease (AD), depression, and Obsessive-Compulsive Disorder (OCD). However, current means to non-invasively modulate brain activity are limited.

The study will evaluate whether sensory flicker can modulate neural activity of deep brain regions in humans, and whether it can have relevant effects on behavior. Moreover, it will compare those effects to the gold-standard method of modulating brain circuits, direct electrical stimulation of the brain (the same mechanism as deep brain stimulation), using a powerful within-subjects design.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adult (>18 years, regardless of gender, race or ethnicity).
  • To be implanted with intracranial depth or grid/strip electrodes for surgical evaluation.
  • Patient was not shown, during phase I seizure monitoring, to exhibit abnormal EEG activity in response to photic stimulation, and is not clinically suspected to be susceptible to photic-induced seizures.
  • Patient has no pre-existing diagnosis of autism.
  • Patient is not considered at risk for psychogenic nonepileptic seizures (PNES) triggered by sensory stimulation.
  • Fluent in English.
  • Able to understand an informed consent (comprehend potential risks and benefits).
  • Give written and verbal informed consent to all experiments patient would participate in.

Exclusion criteria

  • Failure to meet any one inclusion criteria.

Treatment and study plan

Customized version of DAVID device

Device

A customized version of the DAVID device will be used to expose participants to sensory flicker. The device consists of opaque glasses containing LEDs to present flickering light, as well as earbuds or headphones to present flickering sound.

Blackrock CereStim

Device

The Blackrock CereStim is a fully programmable neurostimulator. The current pulses generated by the Blackrock CereStim are intended to stimulate neurons in proximity to a set of electrodes.

Primary outcomes

  1. Fold-change in Oscillatory Activity (Power Spectral Density) in Response to Exposure to Sensory Flicker: Comparing Mean Power Spectral Density at the Frequency of Flicker Being Presented Between Flicker and Baseline Periods

    Time frame: During experiment session (up to 2 hours) during hospital admission (up to 2 weeks)

    The power spectral density of the LFP will be measured across stimulus frequencies and modalities of sensory flicker stimuli in visual areas, auditory areas, hippocampus, and prefrontal cortex. To evaluate the effects of sensory flicker on brain activity in various brain regions, researchers compared the average increase in oscillatory neural activity of given recorded brain regions during sensory stimulation, among the total number of recording locations that showed a significant response to sensory stimulation compared to baseline. In participants in whom a condition was repeated across multiple experimental sessions. If a location showed a significant response in multiple sessions, the data point that showed the highest level of response was kept. The average fold-change increase in oscillatory activity, 25th and 75th percentiles, within a region of interest is reported.

Secondary outcomes

  1. Effect of Sensory Flicker on the Rate of Interictal Epileptiform Discharges (IEDs) Which Represent Pathological Activity Often Observed in Epilepsy

    Time frame: During experiment session (up to 2 hours) during hospital admission (up to 2 weeks)

    The change of of the sensory flicker effect will be evaluated by the comparison of the whole-brain rate of IEDs between sensory flicker stimulation and baseline (no stimulation).

Sponsors and collaborators

Lead sponsor

Emory University

Other

Collaborators

  • Georgia Institute of Technology

Registry information

Official study title

Neurophysiological and Behavioral Effects of Sensory Flicker and Electrical Flicker Stimulation

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Dec 6, 2019
Registry last updated
Mar 26, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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